Quality Systems Technician I

SHIFT: 2nd Shift: 11am - 7:30pm

PURPOSE AND SCOPE:
Ensures that inspections are completed for all incoming materials.  These inspections confirm that the incoming materials meet specific characteristics and specifications set forth by the RM and PK specifications and associated procedures. Responsible for assigning and or performing daily spot-checking of process controls and other processes, such as label control activities and preparation of product samples for internal laboratory analysis or shipment to testing facilities. Reviews quality/production records for accuracy, completeness, and conformance to all applicable procedures.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under general supervision, follows established company policies and procedures and applies acquired job skills to coordinate inspection activities to ensure the work is performed properly.
• Prepares, performs, and controls raw material/packaging material incoming inspections and Material Inspection Reports.
• Performs and maintains process ownership of supplier evaluation activities.
• Participates in cross functional failure investigations and facilitate root cause analysis.
• Performs and maintains calibration service and activities
• Verifies and records the receipt of components and their condition upon arrival.  Documents condition of nonconforming components (description, photographs, etc.) for Material Review Board (MRB) disposition.
• Assigns lot control identification to all incoming production components (chemical components, packaging components, etc.).
• Samples and inspects packaging and chemical components according to approved procedures to ensure conformance with specifications.
• Performs inspections/audits of the process to ensure conformance with SOP procedures and identification as needed.
• Prepares, issues, and reconciles all finished product labels in accordance with established label control procedures. 
• Prepares samples for internal laboratory testing or for shipment to an appropriate testing facility.
• Reconciles all finished product labels.
• Records, counts, and interfaces with issuing facility, and maintains/adjusts the label inventory as necessary.
• Receives and inspects the incoming product labels.
• Maintains effective communication with vendors.
• Enters data in spreadsheets, as assigned for QS records and trending.
• Assist with validations as required.
• Maintains a clean inspection work area.
• Assists with the testing of raw materials in the Chemistry Lab.
• Assembles device history records (DHR) for issuance to production.  
• Reviews finished DHR’s for completeness and correctness.
• Responsible for DHR post production review and compiling – Dry and Liquid.
• Participates in QS Internal Audits to monitor the effectiveness of controls.
• Performs functions that require full knowledge of general aspects of the job.
• Works on assignments that are semi-routine in nature, but recognizes the need for occasional deviation from accepted practice.
• Contacts are typically with individuals within own department and occasionally with contacts outside own organization. 
• May provide assistance to lower level staff with more general support tasks that require a better understanding of functions, as directed by immediate supervisor.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assists with various projects as assigned by direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.
 

PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
May occasionally be required to lift and/or move up to 50 pounds.

EDUCATION:
High School Diploma required.
1 year of college or technical school preferred.

EXPERIENCE AND REQUIRED SKILLS:

• 1 – 2 years of related experience in a chemical, food, or drug manufacturing facility, or in a quality related role.
• Must have good organizational skills, and ability to perform work in a team environment with a minimum level of supervision.
• Must be detail oriented and be capable of interpreting drawings/specifications.
• Must be capable of applying inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications. 
• Must have an aptitude for math with basic algebraic skills and measurement skills.
• General knowledge of GMP regulations and standard quality control inspection techniques.
• Ability to prepare routine administrative paperwork.
• Records maintenance skills.
• Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CRD Part 820 Medical Devices), and Health Canada regulated facilities, if applicable.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.